Ultrabrief Pulsewidth Electroconvulsive Therapy (ECT) (UB ECT)

The University of New South Wales

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Procedure: right-unilateral standard ECT; Procedure: bilateral standard ECT; Procedure: right-unilateral ultrabrief ECT; Procedure: bilateral ultrabrief ECT

Study type: Interventional

Funder types: Other

Identifiers

NCT00870805

UNSW HREC 08322

Details and patient eligibility

About

Electroconvulsive Therapy (ECT) remains essential to contemporary psychiatric practice and is one of the safest and most effective treatments available for depression. Despite modern advances in pharmacotherapy, about 15-20 per cent of all hospitalised patients receive treatment with ECT. Its use, however, is limited by concerns over associated cognitive side effects.

Recent research has suggested that using an ultrabrief pulsewidth with ECT may greatly reduce cognitive side effects, while maintaining efficacy (Sackeim et al 2008). Preliminary results were positive for unilateral ECT, however, suggest that for bilateral ECT, dosing may need to be adjusted to preserve efficacy while reducing side effects. This study will examine the relative cognitive side effects and efficacy of right unilateral and bilateral ECT given with a standard pulsewidth or an ultrabrief pulsewidth. Some participants will also receive an MRI scan before and after ECT.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects meet criteria for a DSM-IV-TR Major Depressive Episode
• Total MADRS score >/= 25
• Age >/= 18 years
• Educated or working in an English medium setting

Exclusion criteria

• Diagnosis (as defined by DSM-IV-TR) of any psychotic disorder (lifetime with exception of Major Depressive Episode with psychotic features); rapid cycling bipolar disorder, eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year).
• history of drug or alcohol abuse or dependence (as per DSM-IV-TR) in the last 6 months (except nicotine and caffeine).
• ECT in last 3 months
• Subject requires an urgent clinical response due to inanition, psychosis or high suicide risk
• unable to give informed consent
• score < 24 on Mini Mental State Examination

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 4 patient groups

bilateral-ultrabrief ECT

Experimental group

Description:

Patients will be treated with an ultrabrief (0.3ms) pulse with a bilateral placement at 3-4 times seizure threshold.

Treatment:

Procedure: bilateral ultrabrief ECT

bilateral standard ECT

Active Comparator group

Description:

Patients will be treated with a standard (1.0ms) pulse with a bilateral placement at 1.5 times seizure threshold.

Treatment:

Procedure: bilateral standard ECT

right-unilateral ultrabrief ECT

Experimental group

Description:

Patients will be treated with an ultrabrief (0.3ms) pulse with a right unilateral placement at 8 times seizure threshold.

Treatment:

Procedure: right-unilateral ultrabrief ECT

right-unilateral standard ECT

Active Comparator group

Description:

Patients will be treated with a standard (1.0ms) pulse with a right unilateral placement at 5 times seizure threshold.

Treatment:

Procedure: right-unilateral standard ECT